Impact of Dairy Consumption on Hypertension: a Clinical Study (PLAT)
Primary Purpose
Hypertension, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dairy diet
Control diet
Sponsored by

About this trial
This is an interventional prevention trial for Hypertension focused on measuring Endothelial function, Dairy
Eligibility Criteria
Inclusion Criteria:
- Men and women aged between 18 and 70 years
- Mean daytime systolic blood pressure ≥ 135 mm Hg and ≤ 160 mm Hg
- Mean daytime diastolic blood pressure ≤ 110 mm Hg
- Consumption of dairy products fewer than 2 servings per day
Exclusion Criteria:
- Mean daytime systolic blood pressure > 160 mm Hg
- Mean daytime diastolic blood pressure > 110 mm Hg
- Dairy intake > 2 serving per day
- Smokers (>1 cigarette/day)
- Body weight variation >10% during the last 6 months prior to the study baseline
- BMI >35 kg/m2
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subject taking anti-inflammatory drugs
- Subject with endocrine or gastrointestinal disorders
- Allergy, intolerance or aversion to dairy
- Clinical use of vitamin D or calcium supplements
- Vegetarians
Sites / Locations
- Institute of Nutraceuticals and Functional Foods (INAF)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dairy diet
Control diet
Arm Description
During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy into their everyday diet.
During the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products into their everyday diet.
Outcomes
Primary Outcome Measures
Change in mean daytime systolic blood pressure
Mean daytime systolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring using the Spacelabs 90207 (Spacelabs, Inc., Redmond, WA)
Secondary Outcome Measures
Change in mean daytime diastolic blood pressure
Mean daytime diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring using the Spacelabs 90207 (Spacelabs, Inc., Redmond, WA)
Change in endothelial function
Digital pulse amplitude will be measured with a PAT device placed on the tip of each index finger (Endo-PAT2000, Itamar Medical, Caesarea, Israel)
Full Information
NCT ID
NCT01776216
First Posted
January 21, 2013
Last Updated
February 6, 2014
Sponsor
Laval University
Collaborators
Dairy Farmers of Canada
1. Study Identification
Unique Protocol Identification Number
NCT01776216
Brief Title
Impact of Dairy Consumption on Hypertension: a Clinical Study
Acronym
PLAT
Official Title
Impact of Dairy Consumption on Hypertension: a Clinical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Dairy Farmers of Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypertension and endothelial dysfunction are being increasingly recognized as key etiological factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). A substantial body of evidence indicates that treating patients with elevated blood pressure (BP) leads to marked reduction in the risk of stroke, myocardial infarction, heart failure, and renal failure. There is also accumulating evidence associating endothelial dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to elevated BP and an increased risk of CVD.
While there are more and more studies on how diet affects BP in healthy subjects, the impact of dairy consumption per se on both endothelial function and ambulatory BP has not been well characterized in patients with established essential hypertension. Therefore, the general objective of the study is to investigate in a single-blind randomized controlled study the impact of dairy consumption on ambulatory BP and endothelial function in subjects with mild to moderate essential hypertension.
Detailed Description
The proposed research will be undertaken as a single-center randomized cross-over controlled study. A total of 80 men and women with mild to moderate essential hypertension but otherwise healthy will consume two 4-week diets, one rich in dairy and one without dairy, while consuming a diet low in saturated fat (<10% energy), in trans fat (<1% energy) and in cholesterol (<200 mg/day). During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (milk, yogurt, cheese) into their every day diet. During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products. The primary analysis consists in comparing mean daytime ambulatory BP values and endothelial function between the two treatments.
A 2-week stabilization run-in period will precede the randomization of participants. During this run-in period, participants will be asked and instructed to adapt their diet to a prudent dietary pattern low in saturated fat (<10% energy), in trans fat (<1% energy) and in cholesterol (<200 mg/day). The total amount of fat in the diet will not be restricted, with recommendations ranging from 25-35% of energy. However, substitution of saturated for unsaturated fat will be advocated. Sodium intake <2300 mg/d will also be recommended. Recommendations will also include advice on how to restrict the consumption of processed and energy dense foods. This 2-week run-in period will allow participants to familiarize themselves with the dietary recommendations used during the intervention per se. The two diets will be separated by a 4-week wash out period and will also consist to the prudent dietary pattern recommended. It must be stressed that foods will not be provided during the run-in and wash-out periods. These periods are imposed to minimize the inter- and intra-individual variability before and between the experimental phases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Diseases
Keywords
Endothelial function, Dairy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dairy diet
Arm Type
Experimental
Arm Description
During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy into their everyday diet.
Arm Title
Control diet
Arm Type
Placebo Comparator
Arm Description
During the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products into their everyday diet.
Intervention Type
Other
Intervention Name(s)
Dairy diet
Other Intervention Name(s)
Dairy products, Milk, Yogourt, Cheese
Intervention Description
During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy: 375 ml of reduced fat milk (1% fat), 175 g of low fat yogurt (1.5% fat) and 30g of regular cheese (34% fat) into their every day diet.
Intervention Type
Other
Intervention Name(s)
Control diet
Intervention Description
During the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products (290 ml of fruit juice, 156 ml of vegetable juice, 1 homemade cookie, 20g of cashew).
Primary Outcome Measure Information:
Title
Change in mean daytime systolic blood pressure
Description
Mean daytime systolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring using the Spacelabs 90207 (Spacelabs, Inc., Redmond, WA)
Time Frame
At the fisrt visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)
Secondary Outcome Measure Information:
Title
Change in mean daytime diastolic blood pressure
Description
Mean daytime diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring using the Spacelabs 90207 (Spacelabs, Inc., Redmond, WA)
Time Frame
At the first visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)
Title
Change in endothelial function
Description
Digital pulse amplitude will be measured with a PAT device placed on the tip of each index finger (Endo-PAT2000, Itamar Medical, Caesarea, Israel)
Time Frame
At the end of the two 4-weeks diets (week 4 and week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged between 18 and 70 years
Mean daytime systolic blood pressure ≥ 135 mm Hg and ≤ 160 mm Hg
Mean daytime diastolic blood pressure ≤ 110 mm Hg
Consumption of dairy products fewer than 2 servings per day
Exclusion Criteria:
Mean daytime systolic blood pressure > 160 mm Hg
Mean daytime diastolic blood pressure > 110 mm Hg
Dairy intake > 2 serving per day
Smokers (>1 cigarette/day)
Body weight variation >10% during the last 6 months prior to the study baseline
BMI >35 kg/m2
Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
Subject taking anti-inflammatory drugs
Subject with endocrine or gastrointestinal disorders
Allergy, intolerance or aversion to dairy
Clinical use of vitamin D or calcium supplements
Vegetarians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Couture, MD,FRCP,PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nutraceuticals and Functional Foods (INAF)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25123170
Citation
Drouin-Chartier JP, Gigleux I, Tremblay AJ, Poirier L, Lamarche B, Couture P. Impact of dairy consumption on essential hypertension: a clinical study. Nutr J. 2014 Aug 14;13:83. doi: 10.1186/1475-2891-13-83.
Results Reference
derived
Learn more about this trial
Impact of Dairy Consumption on Hypertension: a Clinical Study
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